The new EU regulation on medical devices (MDR) has already entered into force. They establish a modern and stronger regulatory framework to protect public health and patient safety. The new rules start to apply after a one-year postponement due to the coronavirus pandemic, addressing the need for greater availability of vitally important medical devices or MDR Clinical Evaluation Report across the EU.
The Regulation covers all medical devices ranging from hip replacements to software or simple adhesive strips. It increases transparency and adapts EU legislation to technological advances and the progress of medical science. It improves clinical safety and creates fair market access for manufacturers.
The new rules improve the safety and quality of medical devices while providing more transparency for patients and less administrative burden for companies.
IMPROVES THE QUALITY, SAFETY AND RELIABILITY OF MEDICAL DEVICES
The new rules contain a number of improvements, including:
It imposes stricter controls on high-risk products, such as implants, and requires the consultation of an EU-level group of experts before medical devices are placed on the market .
Clinical evaluations , investigations and notified bodies approving the certification of medical devices will be subject to more stringent controls.
Strengthens transparency and information for patients, so vital information is easy to find.
Reinforcement of the criteria for the designation and supervision of notified bodies, inclusion of certain aesthetic products that present the same characteristics and risk profile as analogous medical devices within the scope of the regulation;
The European Medical Devices Database ( EUDAMED ) will contain information on each medical device on the market, including economic operators and certificates issued by notified bodies.
Each device will have a unique device identifier so that it can be found in EUDAMED.
More detailed labeling and electronic manuals will increase ease of use.
Implant patients will receive an implant card with all the essential information.
Read More :- MDR Technical Documentation